Clinical trial · Interventional
A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma
TECLIMMY1001-P3: A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Teclistamab, a Humanized BCMA x CD3 Bispecific Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma
NCT04557098CI-TRIAL-00120005MajesTEC-1active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the efficacy of teclistamab at the recommended Phase 2 dose (RP2D).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematological Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Teclistamab | Drug | Teclistamab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Part 3: Teclistamab
- description
- Participants will receive teclistamab subcutaneously (SC) at recommended Phase 2 dose (RP2D) in Cohort A and Cohort C.
- interventionNames
- Drug: Teclistamab
Primary outcomes (1)
- measure
- Cohorts A and C: Overall Response Rate (ORR)
- timeFrame
- Up to 2.9 years
- description
- ORR is defined as the proportion of participants who have a partial response (PR) or better according to the International Myeloma Working Group (IMWG) criteria.
Secondary outcomes (18)
- measure
- Cohorts A and C: Duration of Response (DOR)
- timeFrame
- Up to 2.9 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: - * Documented diagnosis of multiple myeloma according to IMWG diagnostic criteria * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 * Measurable disease: Cohort A and Cohort C: Multiple myeloma must be measurable by central laboratory assessment * A female participant of childbearing potential must have a negative pregnancy test at screening * Willing and able to adhere to the prohibitions and restrictions specified in this protocol * Cohort A: received at least \>=3 prior lines of therapy and previously received a PI, an IMiD and an anti-CD38 monoclonal antibody; Cohort C: received \>= 3 prior lines of therapy that included a PI, an IMiD, an anti-CD38 monoclonal antibody, and an anti-B cell maturation antigen (BCMA) treatment (with CART-T cells or an antibody drug conjugate (ADC) Exclusion Criteria: * Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or primary amyloid light-chain amyloidosis * The following medical conditions: Pulmonary compromise requiring supplemental oxygen use to maintain adequate oxygenation, human immunodeficiency virus (HIV) infection, hepatitis B or C infection, stroke or seizure less than or equal to (\<=) 6 m, autoimmune disease, uncontrolled systemic infection, cardiac conditions (Myocardial Infarction \<= 6 m, stage III-IV congestive heart failure, etc) * Received any therapy that is targeted to BCMA, with the exception of Cohort C in Part 3 * Prior antitumor therapy, within 21 days (PI or radiotherapy within 14 days, IMiDs within 7 days, Gene modified adoptive cell therapy within 3 months) prior to first dose of study drug * Toxicities from previous anticancer therapies that have not resolved to baseline or to \<= grade 1 (except for alopecia or peripheral neuropathy) * Received a cumulative dose of corticosteroids equivalent to \>=140 mg of prednisone within the 14-day period before the first dose of study drug (does not include pretreatment medication) * Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma (MM) * Myelodysplastic syndrome or active malignancies other than relapsed/refractory multiple myeloma with exceptions are: 1) Non-muscle invasive bladder cancer treated within the last 24 months that is considered completely cured 2) Skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured. 3) Noninvasive cervical cancer treated within the last 24 months that is considered completely cured. 4) Localized prostate cancer (N0M0) 5) Breast cancer: Adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer and receiving antihormonal agents and considered to have a very low risk of recurrence. 6) Malignancy that is considered cured with minimal risk of recurrence * Prior allogenic stem cell transplant \<=6 months * Prior autologous stem cell transplant \<=12 weeks * Live, attenuated vaccine within 4 weeks prior to the first dose of teclistamab
References
Publications (18)
- DERIVEDCai Z, Xia Z, He A, Dong Y, Wang Y, Liao A, Song Y, Chen H, Zuppa A, Chastain K, Watkins L, Luo X, Huang L, Xu H, Zhou L, Chen W, Zhu A, Wang X, Du J, Niu T, Fu W. Efficacy and Safety of Teclistamab in Relapsed/Refractory Multiple Myeloma: 2-Year Follow-Up From MajesTEC-1 China Cohort. EJHaem. 2026 Jul 30;7(4):e70340. doi: 10.1002/jha2.70340. eCollection 2026 Aug. PMID 42534634
- DERIVEDVishwamitra D, Skerget S, Cortes-Selva D, Perova T, Lau O, Davis C, Boominathan R, Patel J, Berge KVD, Guo Y, Miao X, Stephenson T, Hodin C, Uhlar C, Pei L, Trancucci D, Zuppa AF, Chastain K, Banerjee A, Kobos R, Bahlis NJ, Van de Donk NWCJ, Verona RI. Longitudinal mechanisms of response, resistance and relapse to teclistamab in multiple myeloma: results from MajesTEC-1. Haematologica. 2026 Jun 11. doi: 10.3324/haematol.2026.300526. Online ahead of print. PMID 42273947
- DERIVEDCarde NAQ, Niu J, Guo Y, Zhou J, Qiu X, Su Y, Perez-Ruixo C, Vishwamitra D, Hodin C, Stephenson T, Zuppa A, Chastain K, Kobos R, Samtani MN, Wang W, Haddish-Berhane N, Van de Donk NWCJ, Garfall AL, Matous JV. Revised Recommendations for Restarting Teclistamab Following Dose Delays: Insights from the MajesTEC-1 Study on Clinical Safety, and from Simulated Pharmacokinetics and Cytokine Dynamics. Target Oncol. 2026 May;21(3):373-383. doi: 10.1007/s11523-026-01205-4. Epub 2026 Mar 26. PMID 41886220
- DERIVEDMartin TG, van de Donk NWCJ, Rodriguez-Otero P, Mateos MV, Kobos R, Chastain K, Doyle M, Nooka AK. Plain language summary of the management of certain side effects of teclistamab in people with multiple myeloma. Future Oncol. 2026 Feb;22(3):285-297. doi: 10.1080/14796694.2025.2597732. Epub 2026 Jan 23. PMID 41574880
- DERIVEDMartin TG, Mateos MV, Yi JH, van de Donk NWCJ, Cai Z, Fu W, Garfall AL, Iida S, Jung SH, Kuroda Y, Niu T, Nooka AK, Min CK, Sidana S, Chastain K, Doyle M, Nishikawa K, Wang X, Song Y, Yamazaki H, Izumi Y, Zhuo J, Zhu A, Yoon DH, Du J, Ishida T. Efficacy and safety of teclistamab in triple-class exposed relapsed/refractory multiple myeloma: Pooled findings from three clinical cohorts and a retrospective cohort. Cancer. 2026 Jan 1;132(1):e70237. doi: 10.1002/cncr.70237.